InjuryFMP
SAMMONS-PRESTON
Received Dec 16, 2025 · Event occurred Apr 10, 2024
Report 3004824601-2025-00184 · MDR key 23816767
Device
Generic name
Polycushion Padding
Manufacturer
Dongguan Guisheng Foam Producing Co-usdModel number
081263565Product problems
- Inadequate Instructions for Healthcare Professional
- Inadequate Instructions for Healthcare Professional
- No Apparent Adverse Event
Patient
Not reported
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
THESE MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED PAST THE REGULATORY REPORTING TIMEFRAME AS THEY ARE A RESULT OF A RETROSPECTIVE REVIEW OF OUR COMPLAINTS.
Description of Event or Problem
ON 10 APR 2024, CUSTOMER COMPLAINT WAS RECEIVED ON 081263565 ROLYAN POLYCUSHION PADDING, BEIGE, 1/8". CUSTOMERS COMPLAINED THAT IT SMELLED AND CAUSED SKIN REACTIONS ON TWO (2) OF THEIR CUSTOMERS.